Endoscopic ablation system with sealed sheath

ABSTRACT

An endoscopic ablation system is provided for use with a flexible endoscope for the ablative treatment of diseased tissue on the interior lining a body lumen. The endoscopic ablation system includes a support member for supporting at least two electrodes that can be electrically connected to a RF generator. The support member also includes a side opening, and can include a sheath having a seal, so that the aspiration means of an endoscope may be used to evacuate the air from inside the body lumen and pull the tissue to be treated into intimate contact with the electrodes on the support member.

CROSS-REFERENCE TO RELATED PATENT APPLICATIONS

[0001] This patent application cross-references and incorporates byreference the following copending, co-filed patent applications:“Endoscopic Ablation System with Flexible Coupling”, Ser. No. 09/______,(Attorney docket END 840) and “Endoscopic Ablation System with ImprovedElectrode Geometry”, Ser. No. 09/______, (Attorney docket END 773).

FIELD OF THE INVENTION

[0002] The present invention relates, in general, to an endoscopicablation system and, more particularly, to an endoscopic ablation systemincluding a plurality of electrodes adapted to fit over a flexibleendoscope and ablate tissue in the esophagus.

BACKGROUND OF THE INVENTION

[0003] Gastro-esophageal reflux disease (GERD), which is associated withsevere heartburn, affects a substantial portion of the world population.People who experience heartburn at least once a week are reportedly atan increased risk of developing esophageal cancer in their lifetime.When left untreated, chronic GERD can cause the inner lining of theesophagus to change from squamous mucosa to columnar mucosa, whichsometimes includes intestinal metaplasia or Barrett's esophagus. Leftuntreated, Barrett's esophagus can progress to esophageal cancer, forwhich a common surgical treatment is esophagectomy (removal of theesophagus.)

[0004] The first step for stopping the progression of these tissuechanges is to reduce the amount of stomach acid that refluxes into theesophagus. This can be done through acid suppression therapy using drugssuch as a proton pump inhibitor or surgically, using a surgicalprocedure such as a Nissan fundoplication. The Nissan fundoplicationprocedure alters the anatomy of the stomach and esophagus to reduce acidreflux. Once the acid reflux has been treated, the condition of theesophagus is monitored over the patient's lifetime to watch foresophageal cancer.

[0005] It has been demonstrated that if the abnormal lining of theesophagus is removed in an acid environment (i.e., after the patient'sGERD has been treated using drugs or surgery), then normal squamouscells will regenerate and the esophageal lining will be restored.Physicians currently use a number of instruments to remove abnormalesophageal tissue, including the Gold Probe™, which is anelectrosurgical ablation device available from Boston Scientific, Inc.and which is introduced through the working channel of a flexibleendoscope. Another ablation instrument that a physician may use for thispurpose is an argon plasma coagulator, which applies a stream of ionizedargon gas to facilitate the flow of electrical current. Examples ofother ablation modalities incorporated into medical instruments that maybe used to ablate tissue in the esophagus include laser and otheroptical devices such as those used in photodynamic therapy (PDT).

[0006] A significant problem with prior art ablation devices used toablate abnormal regions in the mucosa of the esophagus is the surgeon'slack of adequate control over the size, shape and depth of the treatedregion. Prior art devices that use electrodes to ablate abnormal regionsin the mucosa of the esophagus also provide limited visibility of thetreated tissue, thus potentially resulting in damaging adjacent healthytissue, including healthy tissue under the mucosal layer. Further,problems with prior electrosurgical devices used to ablate tissue in theesophagus arise because such instruments ablate tissue directly beneaththe device electrodes. In particular, because the electrodes are opaque,the physician cannot monitor the degree to which tissue under theelectrodes is ablated, making it difficult to determine when to stopapplying electrical current. Further, since ablated or charred tissuetends to stick to electrodes if treated for too long, removing theinstrument may avulse some of the treated tissue away from the wall ofthe esophagus and cause undesirable bleeding.

[0007] The esophagus is a flaccid, tubular organ that has many folds andirregularities on the interior, mucosal lining, especially if diseased.Another significant problem when electrosurgically treating diseasedtissue of the esophagus is supporting the walls of the esophagus inorder to bring the diseased tissue into intimate contact with theelectrodes of the electrosurgical instrument. In addition, the esophagusis not a static structure, but rather contracts frequently due tomuscular, peristaltic action. Another consideration when treating theinterior lining of the esophagus is post-procedural pain due to tissuetrauma associated with passage of instrumentation through theconstricted, curved passages of the throat, especially during intubationof the flexible endoscope.

[0008] Therefore, an improved medical instrument for treating diseasedtissue in the mucosa of the esophagus would provide a physician with theability to accomplish one or more of the following:

[0009] To position accurately the surgical instrument over the tissueregion to be treated, and to do so as atraumatically to the patient aspossible.

[0010] To ablate only the tissue in a specific, predefined area, whichis visible to the surgeon before and during the ablation (and not treattissue that is under the treatment electrodes).

[0011] To stop ablation at the appropriate time in order to controlablation depth.

[0012] To support the walls of the body lumen and bring tissue to betreated into intimate contact with treatment electrodes.

SUMMARY OF THE INVENTION

[0013] The present invention is an endoscopic ablation system for usewith a flexible endoscope for electrosurgically treating bodily tissueof a patient. The endoscopic ablation system comprises at least twoelectrodes electrically connected to an RF generator and positioned on arigid support member of an ablation cap. The rigid support memberincludes a side opening in close proximity to the electrodes. Theendoscopic ablation system can further comprises a sheath attached tothe rigid support member.

[0014] The distal end of the flexible endoscope may be inserted throughthe sheath and at least partially into the ablation end cap. Theendoscopic ablation system can further comprise a seal located near theproximal end of the sheath. The seal is adapted to allow passage of thedistal end of the flexible endoscope, so that the sheath and theablation cap form an enclosure substantially sealed from the airexternal to the patient.

[0015] In one embodiment, the ablation cap can comprise a tapered endcover, which is normally closed and is adapted to open in order to allowpassage of the distal end of the endoscope. In another embodiment, thetapered end cover is normally open and is adapted to allow passage ofthe distal end of the endoscope therethrough. In still anotherembodiment, the tapered end cover is made from a transparent, flexiblematerial, is shaped like a bougie tube, and is adapted to be passed overa guide wire.

[0016] The endoscopic ablation system can also comprise a viewing windowbetween an adjacent pair of electrodes. The viewing window can be madeof a transparent material and form a portion of the rigid supportmember.

[0017] A method of ablating tissue on the interior lining of a lumen ofa bodily organ is also provided. In one embodiment, the method cancomprise providing a support member supporting a first electrode and asecond electrode and having a side opening associated with theelectrodes; positioning the first and second electrodes at a tissue siteto be treated; operatively associating a vacuum source with the sideopening in said support member; and ablating tissue with the electrodes.

[0018] The method can comprise providing a flexible endoscope havingaspiration means, providing an endoscopic ablation system, inserting thedistal end of the flexible endoscope into the sheath and at leastpartially into the ablation cap, intubating the distal end of theflexible endoscope with the sheath and the ablation cap into the lumenof a bodily organ, positioning under endoscopic visualization theviewing window against tissue to be treated, actuating the aspirationmeans on the flexible endoscope to evacuate air and other fluids fromthe lumen of the bodily organ next to the rigid support member, therebycausing the lumen of the bodily organ to collapse around the rigidsupport member, and bringing the viewing window and the electrodes intointimate contact with the interior lining of the lumen of the bodilyorgan, and actuating the RF generator to ablate the tissue between theelectrodes.

[0019] The present invention has application in conventional androbotic-assisted endoscopic medical procedures.

BRIEF DESCRIPTION OF THE DRAWINGS

[0020] The novel features of the invention are set forth withparticularity in the appended claims. The invention itself, however,both as to organization and methods of operation, together with furtherobjects and advantages thereof, may best be understood by reference tothe following description, taken in conjunction with the accompanyingdrawings in which:

[0021]FIG. 1 is an illustration of an endoscopic ablation systemaccording to the present invention mounted on a flexible endoscope.

[0022]FIG. 2 is an enlarged view of an ablation cap at the distal end ofthe endoscopic ablation system illustrated in FIG. 1.

[0023]FIG. 3 is a geometric diagram showing the relative size andposition of two adjacent electrodes that would be mounted on theablation cap illustrated in FIG. 2.

[0024]FIG. 4 is a sectional view of the lower esophagus and the upperstomach of a human being.

[0025]FIG. 5 illustrates the use of the endoscopic ablation system ofFIG. 1 to treat tissue at the lower esophagus.

[0026]FIG. 6 is sectional view of the lower esophagus showing tissuethat has been treated using the endoscopic ablation system of FIG. 1.

[0027]FIG. 7 illustrates an alternative embodiment of an endoscopicablation system, which includes a rotation knob 58 and a valve 60 (alsoreferred to as a tapered end cover).

[0028]FIG. 8 is a sectional view of the distal end of the endoscopicablation system illustrated in FIG. 7.

[0029]FIG. 9 is a sectional view taken at line 9-9 of the endoscopicablation system illustrated in FIG. 8.

[0030]FIG. 10 is a sectional view taken at line 10-10 of the endoscopicablation system illustrated in FIG. 8.

[0031]FIG. 11 is an illustration of a further embodiment of anendoscopic ablation system, which includes an electrode sled 70.

[0032]FIG. 12 is an enlarged, perspective view of the distal portion ofthe endoscopic ablation system illustrated in FIG. 11, showing electrodesled 70 in an extended position.

[0033]FIG. 13 is an enlarged, perspective view of the distal portion ofthe endoscopic ablation system illustrated in FIG. 11, showing electrodesled 70 in a retracted position.

[0034]FIG. 14 is an enlarged, top view of the distal portion of theendoscopic ablation system illustrated in FIG. 11, showing electrodesled 70 in the extended position.

[0035]FIG. 15 is an enlarged, sectional side view of the distal portionof the endoscopic ablation system illustrated in FIG. 11, showingelectrode sled 70 in the extended position.

[0036]FIG. 16 is an enlarged, end view of the distal portion of theendoscopic ablation system illustrated in FIG. 11.

[0037]FIG. 17 is an illustration of a further embodiment of anendoscopic ablation system, which includes a tapered end cover 84 and atimer 91.

[0038]FIG. 18 is a sectional view of the distal portion of theendoscopic ablation system shown in FIG. 17, wherein a plurality ofelectrodes 28 are mounted on the tapered end cover 84 near a distal tip104.

[0039]FIG. 19 is a sectional view of the distal portion of theendoscopic ablation system shown in FIG. 17, wherein a plurality ofelectrodes 28 are mounted on a rigid support member 26.

[0040]FIG. 20 is a sectional view of the distal portion of theendoscopic ablation system shown in FIG. 17, wherein a plurality ofelectrodes 28 are mounted partially on rigid support member 26 andpartially on tapered end cover 84.

[0041]FIG. 21 is a sectional view of the proximal portion of theendoscopic ablation system shown in FIG. 17.

[0042]FIG. 22 is a sectional view of the mouth and throat of a patientduring intubation of the endoscopic ablation system shown in FIG. 17.

[0043]FIG. 23 is a sectional view of the distal portion of a furtherembodiment of an endoscopic ablation system, which includes an open-endpiece 114 (also referred to as a tapered end cover).

[0044]FIG. 24 is a graph showing the relationship of an Ablation Qualityto an Ablation Index “I”, for the endoscopic ablation system accordingto the present invention.

DETAILED DESCRIPTION OF THE INVENTION

[0045]FIG. 1 shows an endoscopic ablation system 10 according to thepresent invention mounted on a flexible endoscope 12 (also referred toas endoscope 12), such as the GIF-100 model available from OlympusCorporation. Flexible endoscope 12 includes an endoscope handle 34 and aflexible shaft 32. Endoscopic ablation system 10 generally comprises anablation cap 20, a plurality of conductors 18, a handpiece 16 having aswitch 62, and an RF (radio frequency) generator 14. Ablation cap 20fits over the distal end of flexible shaft 32 and conductors 18 attachto flexible shaft 32 using a plurality of clips 30. Ablation cap 20includes a rigid support member 26, a plurality of electrodes 28, and aviewing window 29 positioned between electrodes 28. In this embodiment,rigid support member 26 is made of a transparent material such aspolycarbonate and viewing window 29 is the portion of rigid supportmember 26 between electrodes 18. Manual operation of switch 62 ofhandpiece 16 electrically connects or disconnects electrodes 18 to RFgenerator 14. Alternatively, switch 62 may be mounted on, for example, afoot switch (not shown).

[0046] RF generator 14 is a conventional, bipolar/monopolarelectrosurgical generator such as one of many models commerciallyavailable, including Model Number ICC 350, available from Erbe, GmbH.Either the bipolar mode or the monopolar mode may be used for thepresent invention. When using the bipolar mode with two electrodes 18 onablation cap 20, one electrode is electrically connected to one bipolarpolarity, and the other electrode is electrically connected to theopposite bipolar polarity. If more than two electrodes 18 are used,polarity of electrodes 18 is alternated so that any two adjacentelectrodes have opposite polarities. When using the monopolar mode withtwo or more electrodes 18, a grounding pad is not needed on the patient.Rather, a custom impedance circuit easily made by one skilled in theart, is electrically connected in series with one of conductors 18 thatmay normally be used with a grounding pad during monopolarelectrosurgery. The optimal power level required to operate endoscopicablation system 10 of the present invention is approximately in therange of 10-50 watts, although endoscopic ablation system 10 is alsofunctional at lower or higher power levels.

[0047]FIG. 2 is an enlarged view of ablation cap 20 of endoscopicablation system 10 shown in FIG. 1. Ablation cap 20 fits securely overthe distal end of flexible shaft 32. Electrodes 28 are positioned on theoutside surface of rigid support member 26, which has a circularcylinder shape in this embodiment. Rigid support member 26 may also havealternate cylindrical shapes, including shapes in which at least aportion of the cross sectional perimeter is non-arcuate. For example,rigid support member 26 may have a “D-shape” cross-section, whereelectrodes 28 are positioned on the flat portion of the “D-shape.”Conductors 18 are electrically insulated from each other and surroundingstructures, except for electrical connections such as to electrodes 28.The distal end of flexible shaft 32 of flexible endoscope 12 includes alight source 40, a viewing port 38, and a working channel 36. Viewingport 38 transmits an image within its field of view to an optical devicesuch as a CCD camera within flexible endoscope 12 so that an operatormay view the image on a display monitor (not shown). In the embodimentshown in FIG. 2, the distal end of flexible shaft 32 is proximal toelectrodes 28 and viewing window 29, enabling the operator to see tissuebetween electrodes 28 through viewing window 29.

[0048]FIG. 3 shows the geometric relationship of a particular embodimentof electrodes 28. In this embodiment, two rectangular electrodes 28,also referred to as first and second electrodes, each having a width “w”and a length “L”, have parallel, adjacent edges 8 that are separated bya distance “d”. This geometric relationship may be used to calculate anablation index, which has particular significance to the location, size,shape, and depth of ablation achievable, as will be described later.Viewing window 29 (see FIG. 2) is approximately defined by the d×Lrectangular area between electrodes 28.

[0049]FIG. 4 is a sectional view of a lower esophagus 42 and the upperportion of a stomach 54 of a human being. Lower esophagus 42 has amucosal layer 46, a muscular layer 44, and a region of diseased tissue48. The boundary between mucosal layer 46 of lower esophagus 42 and agastric mucosa 50 of stomach 54 is a gastro-esophageal junction 52,which is approximately the location for the lower esophageal sphincter(LES). The LES allows food to enter the stomach 54 while preventing thecontents of stomach 54 from refluxing into lower esophagus 42 anddamaging mucosal layer 46. Diseased tissue 48 can develop when chronicreflux is not treated. In one form, diseased tissue 48 may be, forexample, intestinal metaplasia, which is an early stage of Barrett'sesophagus.

[0050]FIG. 5 illustrates the use of endoscopic ablation system 10 totreat diseased tissue 48 in lower esophagus 42. The operator positionsablation cap 20 using endoscopic visualization so that diseased tissue48 to be treated lies under viewing window 29.

[0051]FIG. 6 is sectional view of lower esophagus 42 showing tissue thathas been treated using endoscopic ablation system 10 according to thepresent invention. In FIG. 6, the size and shape of the treated tissue56 substantially corresponds to the size and shape of viewing window 29.

[0052] The operator may treat diseased tissue 48 using the embodiment ofendoscopic ablation system 10 of the present invention shown in FIGS. 1and 5 as follows. The operator inserts flexible shaft 32 of endoscope 12into lower esophagus 42 trans-orally. Rigid support member 26 holdslower esophagus 42 open as the operator uses endoscopic visualizationthrough ablation cap 26 to position electrodes 28 next to the diseasedtissue 48 to be treated. Rigid support member 26 opens and supports aportion of the lower esophagus 42 and helps to bring the tissue to betreated into intimate contact with electrodes 28 and viewing window 29.While watching through viewing window 29, the operator actuates switch62, electrically connecting electrodes 28 to RF generator 14 throughconductors 18. Electric current then passes through the diseased tissuepositioned in viewing window 29. When the operator observes that thetissue in viewing window 29 has been ablated sufficiently, the operatordeactuates switch 62 to stop the ablation. The operator may repositionelectrodes 28 for subsequent tissue treatment, or may withdraw ablationcap 26 (together with flexible endoscope 12). As illustrated in FIG. 6,treated tissue 56 has substantially the same width and length as viewingwindow 29.

[0053]FIG. 7 shows an alternate embodiment of an endoscopic ablationsystem 10 and generally comprises an ablation cap 20, a sheath 63, apair of conductors 18, a handpiece 16 having a switch 62, and an RFgenerator 14. An operator may rotate ablation cap 20 around flexibleshaft 32 of flexible endoscope 12 by manipulation of a rotation knob 58,which connects to sheath 63. Ablation cap 20 includes a rigid supportmember 26, at least two electrodes 28, and at least one viewing window29 (between each pair of adjacent electrodes). Sheath 63 comprises arotation tube 22 covered by an external tube 64. Ablation cap 20attaches directly to the distal end of sheath 63. Rotation tube 22 ismade from a stiff tube material such as, for example, corrugatedpolyethylene tubing, and fits slidably over a conventional, flexibleendoscope. External tube 64 is preferably made from a heat-activatedshrink tube material such as polyolefin. Conductors 18 are spirallywrapped around rotation tube 22 prior to assembling and shrinkingexternal tube 64 onto rotation tube 22, thereby tightly retainingconductors 18 in the wound configuration. In the embodiment shown inFIG. 7, a valve 60 (also referred to as a tapered end cover), which maybe, for example, a duck bill valve, connects to the distal end of rigidsupport member 26. Valve 60 allows an operator to extend the distal endof flexible endoscope 12 beyond the distal end of rigid support member26 to improve visualization of tissue structures, especially duringintubation. The operator may also retract the distal end of flexibleendoscope 12 within rigid support member 26 to allow visualization ofviewing window 29 and electrodes 28, while preventing bodily fluids fromentering rigid support member 26 and impairing visualization by contactwith flexible endoscope 12.

[0054] Alternate embodiments of valve 60 may be envisioned by thoseskilled in the art, each embodiment being particularly adapted to themedical procedure and anatomical structures involved. For example, in analternative embodiment of the present invention, the distal end of valve60 could be further tapered and elongated to allow for easier insertioninto the esophagus. Valve 60 could further be transparent to enable thephysician to visualize through valve 60 during intubation into theesophagus, while preventing contact of bodily fluids against the distalend of flexible endoscope 12.

[0055]FIG. 8 is a sectional view taken along the longitudinal axis ofendoscopic ablation system 10 of FIG. 7. The distal portion of flexibleshaft 32 is inside rotation tube 22 of endoscopic ablation system 10. Apair of conductors 18 passes through a strain relief 66 of rotation knob58 and between external tube 64 and rotation tube 22. Each conductor 18connects electrically to one of electrodes 28 on ablation cap 20.Rotation tube 22 rotatably joins rotation knob 58 to ablation cap 20,enabling the operator to rotatably orient electrodes 28, even afterinsertion into the esophagus, by remotely actuating rotation knob 58.The distal end of flexible shaft 32 extends from the distal end ofsheath 63 into ablation cap 20 and proximal to electrodes 18. A viewingwindow 29 between electrodes 28 is within the field of view of flexibleendoscope 12, thus enabling the operator to see on a display monitor thetissue that is located between electrodes 18. Valve 60 extends from thedistal end of ablation cap 20 to prevent tissue or fluids from enteringablation cap 20.

[0056]FIG. 9 is a sectional view taken along line 9-9 of ablation cap 20of endoscopic ablation system 10 of FIG. 8. Conductors 18 connect toelectrodes 28 with the portion of rigid support member 26 betweenelectrodes 28 defining viewing window 29. Rotation tube 22 retainsflexible shaft 32. The inside diameter of rotation tube 22 is largerthan the outer diameter of flexible endoscope 12 to allow rotation ofrotation tube 22 while holding flexible endoscope 12 stationary, or viceversa. In this embodiment at least the portion of rigid support member26 that forms viewing window 29 is transparent so that the operator mayendoscopically view the tissue between electrodes 28. Flexible endoscope12 includes a light source 40, a viewing port 38, and a working channel36.

[0057]FIG. 10 is a sectional view taken along line 10-10 of rotationtube 22 of endoscopic ablation system 10 of FIG. 8. External tube 64 androtation tube 22 assemble and retain conductors 18 as already described.Light source 40, viewing port 38, and working channel 36 of flexibleendoscope 12 are shown.

[0058]FIG. 11 shows a further embodiment of an endoscopic ablationsystem 10 according to the present invention. A flexible ablation cap 24includes a flexible support member 68 and at least two electrodes 28mounted on an electrode sled 70, which may be housed in or extended froma sled housing 76. Flexible ablation cap 24 mounts over the distal endof flexible shaft 32. Conductors 18 electrically connect to electrodes28 as in the previous embodiments, and may be attached to flexible shaft32 by a plurality of clips 30. Again, conductors 18 electrically connectto RF generator 14 by a switch 62 of a handpiece 16.

[0059]FIG. 12 is an enlarged view of flexible ablation cap 24 of theendoscopic ablation system 10 illustrated in FIG. 11 with electrode sled70 fully extended. A sled housing 76 is a soft and flexible, pouch-likecontainer, which may be made of a material such as PTFE in order toprevent damage to the mucosa as the operator introduces endoscopicablation system 10 into the esophagus. Sled housing 76 and flexiblesupport member 68 may be molded as a single piece. Electrode sled 70 maybe made of a clear rigid material such as, for example, polycarbonate.As shown in FIG. 12, electrode sled 70 includes two electrodes 28, aviewing window 29, and two conductors 18. At least the portion ofelectrode sled 70 that forms viewing window 29 is transparent to allowthe operator to view endoscopically the tissue between electrodes 28.Flexible support member 68 includes sled guides 78, which are adapted toreceive electrode sled 70. Extension of sled 70 to an extended positionstiffens flexible support member 68 such as may be desired duringablation; retraction of sled 70 to a retracted position allows flexiblesupport member 68 to flex such as may be desirable during intubation. Adrive cable 74, which retains conductors 18, extends proximally throughsled housing 76 and into a sleeve 72. Sleeve 72 attaches to flexibleshaft 32 by a fixed clip 31. Thus, by extending drive cable 74,electrode sled 70 moves distally and, by retracting drive cable 74,electrode sled 70 moves proximally into sled housing 76.

[0060]FIG. 13 shows flexible ablation cap 24 of endoscopic ablationsystem 10 of FIG. 11 with electrode sled 70 retracted into sled housing76, or in a retracted position.

[0061] FIGS. 14-16 are additional views of flexible ablation cap 24illustrated in FIG. 11. FIG. 14 is a top view of flexible ablation cap24 with electrode sled 70 in an extended position. FIG. 15 is asectional view taken at line 15-15 of FIG. 14 of flexible ablation cap24 with electrode sled 70 in an extended position. In FIGS. 14 and 15electrode sled 70 includes electrodes 28, viewing window 29 andconductors 18, which are connected to electrodes 28. Flexible supportmember 68 includes sled guides 78. Drive cable 74, which housesconductors 18, is in turn housed within sled housing 76 and extendsproximally into sleeve 72. FIG. 16 is an end view of the flexibleablation cap 24 of the endoscopic ablation system 10 illustrated in FIG.11. FIG. 16 illustrates the arrangement of sled guides 78 and theengagement of electrode sled 70 by sled guides 78.

[0062]FIG. 17 is an illustration of a further embodiment of anendoscopic ablation system 10 for use with an endoscope 12 having anendoscope handle 34. Endoscopic ablation system 10 generally comprises arotation knob 58, a sheath 63, an ablation cap 82, and a tapered endcover 84. Ablation cap 82 further includes an ablation cap-opening 86.Conductors 18 spirally wrap around the outside of sheath 63 in thisembodiment, and at least one clip 30 attaches conductors 18 to sheath63. Endoscopic ablation system 10 further comprises an actuator 90 and atimer 91. A plurality of electrodes 28 (hidden in this view) on ablationcap 82 electrically connect, via a pair of conductors 18, to actuator90. The operator actuates actuator 90 manually to enable timer 91 toelectrically connect electrodes 28 to RF generator 14 for apredetermined period of time. The operator then actuates control switch92, which may be a foot operated control switch commonly available withRF generators, to activate RF generator 14. When RF generator 14 isactivated, timer 91 automatically connects RF generator 14 to electrodes28 for a predetermined length of time. For the embodiments of anendoscopic ablation system described herein, an appropriatepredetermined length of time is approximately in the range of 0.1 to 10seconds, and is preferably about one second. However, the length ofpredetermined time may vary depending on the geometry of the electrodes,the power level used on the RF generator, the type of tissue beingtreated, and other factors. Timer 91 includes a conventional timercircuit that is connected in electrical series to the output of a RFgenerator 14 having a control switch 92. When the operator actuatescontrol switch 92, the electrical current from RF generator 14 induces asecondary current inside of timer 91. This secondary current suppliesand immediately activates the timer circuit of timer 91, therebyconnecting the output of RF generator 14 to electrodes 28 via a relayinside of timer 91. After a predetermined period of time, the relaydisengages automatically, therefore electrically disconnecting RFgenerator 14 from the electrodes 28. Therefore, the operator controlswhen electrodes 28 are energized to begin ablation of tissue, but timer91 controls when ablation stops, even though the operator may still beactivating control switch 92. Timer 91 ensures complete ablation ofdiseased tissue in the viewing window and greatly reduces thepossibility of operator error associated with RF energy application.

[0063] Timer 91 and actuator 90 of FIG. 17 may be provided as a handlewith a switch much like handle 16 and switch 62 of FIG. 1. Alternately,timer 91 and actuator 90 may be incorporated into a table top unit (notshown), combined with RF generator 14 and control switch 92, orelectronically packaged in many other ways that are readily apparent toone skilled in the art. Actuator 90, timer 91, RF generator 14, andcontrol switch 92 may comprise a reusable portion of endoscopic ablationsystem 10. The remaining portion that includes conductors 18, sheath 63,rotation knob 58, and ablation cap 82 may be provided, for example, as arelatively low cost, sterile device that is disposable after use on onepatient.

[0064]FIGS. 18, 19, and 20 are sectional views of the distal portion ofendoscopic ablation system 10 shown in FIG. 17, and illustrate alternatelocations of electrodes 28. FIGS. 18, 19, and 20 show the distal end ofsheath 63 inserted into the proximal end of a flexible coupling 88 andattached by a ring 94 tightly compressed around sheath 63 and theproximal end of flexible coupling 88. The distal end of flexiblecoupling 88 attaches to the proximal end of a rigid support member 26 ofablation cap 82 by the engagement of a plurality of annular projections96 on the inside of the distal end of flexible coupling 88 with a likeplurality of annular grooves 98 formed into the proximal end of rigidsupport member 26. Flexible coupling 88 is made of a flexible tubematerial such as silicone rubber and allows low force angulation ofsheath 63 with respect to ablation cap 82, thus facilitating passage ofablation cap 82 through the esophagus of the patient. The distal end ofrigid support member 26 includes a plurality of annular grooves 99 forretaining a plurality of annular projections 97 on the inside of theproximal end of tapered end cover 84. Tapered end cover 84 is made of atransparent, flexible material such as, for example, clear or tintedpolyurethane that is commonly used for flexible, extruded tubing.Tapered end cover 84 further includes an elongated, distal tip 104 thathelps the operator to insert ablation cap 82 into the esophagus.

[0065] Tapered end cover 84 is hollow in order to allow positioning ofthe distal end of endoscope 12 partially into tapered end cover 84, asshown in FIG. 18. This enables the operator to view the interior of theesophagus, yet protects the distal end of endoscope 12 from tissuestructures and bodily fluids that may impair visualization. Tapered endcover 84 is shaped like a bougie tube, which is commonly used byendoscopists for dilating the esophagus prior to intubation with anendoscope. Distal tip 104 of tapered end cover 84 includes a channel 102so that the operator may pass a guide wire through ablation cap 82 andsheath 63, in order to facilitate positioning of ablation cap 82 insideof the esophagus. Gastroenterologists commonly use a guide wire that isinserted into the esophagus to guide, for example, a dilating instrumentinto the esophagus.

[0066] As shown in FIGS. 18, 19, and 20, electrodes 28 may be mounted atvarying locations on ablation cap 82. In FIG. 18, electrodes 28 areattached to the outside of tapered end cover 84 near distal tip 104. Asindicated in FIG. 18, electrodes 28 are positioned on a portion oftapered end cover 84 that has a smaller cross-sectional diameter thanthe diameter of the distal end of endoscope 12. As shown in FIG. 19,electrodes 28 may also be attached to rigid support member 26, as wasalso described for the embodiments shown in FIGS. 1 and 7. In FIG. 19, aportion of one of conductors 18 is shown as it may be electricallyconnected to one of electrodes 28 by a solder and/or compressionconnection. (Conductors 18 are not shown in FIGS. 18 and 20.) In FIG.20, electrodes 28 are positioned partially on rigid support member 26and partially on tapered end cover 84. Electrodes 28 may vary in size,shape, and position on ablation cap 82, as shown in the examples ofFIGS. 18, 19, and 20, but importantly, still follow the geometricrelationships described for FIG. 3 in order to achieve a desiredablation quality.

[0067] Still referring to FIGS. 18, 19, and 20, rigid support member 26also includes side opening 86. In the examples shown, side opening 86 isrectangularly shaped and positioned between the distal end of flexiblecoupling 88 and the proximal end of tapered end cover 84. In theexamples shown in FIGS. 19 and 20, side opening 86 is on the side ofrigid support member 26 opposing the position of electrodes 26. Sideopening 86 can be positioned substantially 180 degrees opposite of theviewing window 29. Side opening 86 provides access to tissue structuresnext to ablation cap 82 with instrumentation passed through the workingchannel of endoscope 12. In addition, side opening 86 allows fluidcommunication between endoscope 12 (that normally includes suction andirrigation channels) and the interior of the esophagus around ablationcap. Therefore, the operator may position electrodes 28 adjacent totissue to be ablated and apply the suction provided with endoscope 12.As the lumen size of the esophagus decreases under vacuum, the esophaguscollapses around ablation cap 82, thus bringing the tissue to be treatedin intimate contact with electrodes 28 and viewing window 29. Thisfacilitates uniform electrode contact for even ablation, and improvesendoscopic visualization through the viewing window of tissue beingtreated during the procedure.

[0068] It is believed that support member 26 can aid in stabilizing theshape of the lumen (such as the esophagus) during a medical procedure,such as ablation. In particular, the tissue of the esophagus can conformto the outside shape of the rigid support member 26, to help ensurecontact of the ablation electrodes with the tissue to be treated. Inaddition, it is believed that the side opening 86 can assist instabilizing the shape of the esophagus and ensuring proper contact ofelectrodes or other ablation device with the tissue to be treated.

[0069] The side opening 86 can be operatively associated with suction,such as by being in flow communication with a vacuum source. Forinstance, a vacuum can be communicated to the side opening 86 throughsheath 63 or through a vacuum device associated with an endoscope suchas endoscope 12. As described above, suction provided through sideopening 86 can assist in collapsing the esophagus around the supportmember 26 to assist in conforming the tissue of the esophagus to theoutside surface of the support member and into contact with ablationelectrodes, such as electrodes 28.

[0070] In some treatment applications, folds or other irregularities inthe tissue of the lumen being treated may make it difficult to accesstissue to be treated. For instance, the folds or irregularities in thetissue of the esophagus may result in circumferential expanse ofesophageal tissue which is substantially larger than the circumferenceof the outside surface of the support member 26. In order to providesuitable contact of the tissue to be treated with ablation electrodes,the support member 26 can be positioned in the esophagus where treatmentis desired, and suction communicated through side opening 86 to draw thetissue into contact with the support member 26. With suction activated,the support member 26 can be rotated about it's central axis. Suchrotation can be through an angle sufficient to pull on the tissue, suchas in a generally circumferential direction and generally tangential toesophageal tissue at the side opening 86. The rotation can be used todraw on and straighten or otherwise extend at least a portion of thefolds or irregularities in the esophagus to provide a relatively flattissue surface as viewed through viewing window 29. The electrodes 28can then be activated to treat the tissue visible in viewing window 29.The electrodes can be deactivated upon proper ablation of the tissue.The suction can be deactivated as need to reposition the support member26 in the esophagus. The procedure can be repeated in incremental stepsaround the circumference of the esophagus to provide treatment asneeded.

[0071] Side opening 86 provides a further benefit in that one or moreadditional instruments can be introduced through the sheath or endoscopeto access tissue through side opening 86. For example, a tissue forcepsdevice can be advanced through the sheath or through an endoscope withinthe sheath to access tissue and obtain a tissue sample through the sideopening 86. Alternatively, a separate electro-cautery device could beused to ablate tissue exposed through side opening 86. In still anotherembodiment, a support member 26 having a side opening 86 can be providedwithout electrodes 28, and ablation can be provided with a separateelectrode assembly, such as an electrode assembly advanced through thesheath 63 or the endoscope.

[0072]FIG. 21 is a sectional view of the proximal portion of sheath 63,rotation knob 58, and conductors 18 of the endoscopic ablation system 10shown in FIG. 17. Rotation knob 58 is molded from a flexible materialsuch as a biocompatible rubber. The proximal end of rotation knob 58includes a proximal seal 110 having a hole 111 for insertion ofendoscope 12 (not shown). The interior of the sheath distal to proximalseal 110 and the interior of ablation cap 82 define an enclosure that isin fluid communication with the interior of the esophagus and theaspiration means of the flexible endoscope 12. Proximal seal 110prevents fluid communication between the air external to the patient andthe interior of sheath 63 and the interior of ablation cap 82. Thisallows the technique described for FIGS. 18, 19, and 20 for using thesuction available with endoscope 12 to pull the interior of theesophagus into intimate contact with electrodes 28 and viewing window29. Seal 110 also wipes bodily fluids from the exterior of endoscope 12as it is withdrawn from sheath 63. Rotation knob 58 also includes adistal cylindrical extension 57 that fits tightly over the proximal endof a rotation tube 22 of sheath 63. An external tube 64 fits tightlyover the entire length of sheath 63, including the portion attached todistal cylindrical extension 57 of rotation knob 58. Rotation tube 22may be made of any one of a number of flexible tubing materials,including corrugated polyethylene tubing. External tube 64 is preferablymade from polyolefin that is shrink-wrapped tightly onto rotation tube22 by the application of heat during assembly. In FIG. 21, conductors 18are shown wrapped around the outside of sheath 63. Conductors 18 mayalso be assembled between rotation tube 22 and external tube 64 so thatthe outside of sheath 63 is relatively smooth for passage into theesophagus. Rotation knob 58 also includes a plurality of gripprojections 112 to facilitate manipulation.

[0073]FIG. 22 shows the distal portion of endoscopic ablation system 10of FIG. 17 partially inserted into the esophagus 41 of a patient.Tapered end cover 84 dilates esophagus 41 as the operator gently insertsablation cap 82 for positioning near tissue to be ablated. Flexiblecoupling 88 flexes as shown, reducing the required insertion force andminimizing trauma (and post-procedural pain) to the patient.

[0074]FIG. 23 is a sectional view of the distal portion of a furtherembodiment of an endoscopic ablation system 10. FIG. 23 shows anendoscope 12 inserted into an ablation cap 116 that includes a sheath63, a plurality of electrodes 28, and a flexible coupling 88 such as wasdescribed for FIG. 19. However the embodiment in FIG. 23 includes anopen-end piece 114 (also referred to as a tapered end cover) attached tothe distal end of rigid support member 26. Open-end piece 114 resemblestapered end cover 84 of FIG. 17, but with all but the proximal portioncut off perpendicular to the longitudinal axis. The remaining taper ofopen-end piece 114 facilitates passage through the esophagus andsubstantially prevents body fluids on the esophageal wall fromcollecting inside ablation cap 116. Open-end piece 114 is madepreferably from a flexible material such as silicone rubber. Theoperator may extend the distal end of endoscope 12 through open-endpiece 114, to facilitate endoscopic visualization during intubation ofablation cap 116 into the esophagus. The operator may retract endoscope12 to a retracted position as shown in FIG. 23 in order to view tissuethrough a viewing window (not shown) between adjacent electrodes 28, andto watch the progress of ablation.

[0075] Now referring again to FIG. 3, the size, shape, and relativeposition of electrodes 28 are shown, as they would be mounted on rigidsupport member 26. The region between electrodes 28 forms viewing window29. In an endoscopic ablation system according to the present invention,the size, shape and relative position of electrodes 28 are establishedby the Ablation Index, I, and:

I=P/d  (1)

[0076] Where:

[0077] P is the perimeter of electrodes 28 and

[0078] d is the separation between adjacent edges 8 of electrodes 28.

[0079] In the embodiment of the invention illustrated in FIG. 3:

I=2(w+L)/d  (2)

[0080] Where:

[0081] w is the width of electrodes 28 and

[0082] L is the length of electrodes 28.

[0083] Suitable ablation indices can be provided wherein: the separationd can be between about 1 mm and about 3 mm; L can be between about 20 mmand about 40 mm; and w can be between about 3 mm and about 8 mm. Inparticular, d can be less than or equal to about 2 mm. Moreparticularly, electrode size and spacing of d equal to 2 mm, L equal to30 mm, and w equal to 5 mm can be used to provide an Ablation IndexI=35. In another embodiment, an electrode size and spacing of d equal to2 mm, L equal to 20 mm, and w equal to 5 mm can be used to provide anAblation Index I=to 25.

[0084] Although the electrodes illustrated in FIG. 3 are rectangular inshape, other shapes having an Ablation Index I according to Equation 1are appropriate for use in the present invention provided that d issubstantially constant, i.e. the adjacent edges of the electrodes aresubstantially parallel and/or equidistanced apart. In an endoscopicablation system according to one embodiment of the present invention,1<I<200 and, preferably, I can be greater than or equal to about 15 andI can be less than or equal to about 35. In FIG. 24, region A includes arange of I from about 13 to about 36.

[0085] The graph of FIG. 24 is based on data derived from experimentswith different electrode geometries for RF power levels varying between10 and 50 watts. A pair of mirror image, rectangular electrodes was usedfor each experiment. The width w was varied between 1-10 mm; the lengthL was varied between 5-50 mm; the distance d was varied between 1-5 mm.The experiments were performed on soft, muscular porcine tissue having atemperature and moisture content similar to conditions inside the lumenof a human esophagus. For each experiment, the electrodes were broughtinto intimate contact with the tissue. The time of ablation variedbetween 1-3 seconds. The RF generator was activated only for the lengthof time required for at least a portion of the tissue in the viewingwindow to turn white. The ablated tissue was then sectioned order toapproximate ablation depth and to look for uniformity of ablation depth.Two observers then assigned an Ablation Quality, which is a subjectiverating of between 1-10. A low Ablation Quality equal to 1 corresponds toan experiment in which ablation occurred only underneath the electrodesand, in some experiments, around the outer edges of the electrode, andnot in the tissue between the electrodes. An Ablation Quality of 10corresponds to an experiment in which ablation occurred only between theelectrodes (and visible through the viewing window) and not underneaththe electrodes. An Ablation Quality of 5 corresponds to an experiment inwhich about half of the area under the electrodes was ablated, and aboutall of the area between the electrodes was ablated. A high AblationQuality>5 also corresponds to experiments in which the tissue wasablated to a uniform depth of approximately 1 mm. An ablation depth ofapproximately 1 mm is normally sufficient to destroy diseased tissue inthe mucosal and submucosal layers of the human esophagus withoutdamaging the muscular layers of the esophagus.

[0086] In FIG. 24, region A indicates the Ablation Index I for whenAblation Quality is greater than or equal to 5 (an average subjectiverating) on a scale of 1-10. In some cases, the operator may desire tomaintain an ablation index where I is greater than or equal to about 20and less than or equal to about 28 or 29, as indicated by a region “B”in FIG. 24. Practical considerations related to manufacture, type oftissue being treated, physician preferences, and so on, come into playwhen determining electrode geometry and selecting an ablation indexrange. The Ablation Index is used to define an electrode arrangementthat substantially confines the initial ablation to the tissue under theviewing window, allowing the operator to control the ablation process.Such an endoscopic ablation instrument will begin to ablate tissue whenan electric potential is established between the electrodes (i.e. theelectrodes are actuated). However, during the initial ablation processlittle or none of the tissue directly beneath the electrodes will beablated and the thermal profile within the treated tissue will have asubstantially vertical wall at the edge of the electrodes. Further, thecurrent density of the electrical current flowing between the electrodeswill be very high in the tissue under the viewing window, acceleratingthe ablation of tissue within the treatment region, giving the operatorprecise control of the treatment region and limiting the ablation ofhealthy tissue. The operator further has precise control of the degreeto which the treated tissue is ablated since the operator may view theentire treatment region through the viewing window. The operator mayvisually determine when the treated tissue is sufficiently ablated bywatching to see when the ablated tissue fills the entire ablationwindow. When the ablated tissue fills the entire ablation window, themucosa is consistently ablated to a predetermined depth across thetreatment region. The actual depth of the ablation is a function of anumber of variables, including power. In one preferred combination,Ablation Index I=25 and RF power equals 30 watts, and the electrodes areenergized for 1.3 seconds. Uniform ablation depths of approximately oneto two millimeters can be constantly obtainable using the color of thetreated tissue in the ablation window as a guide. Ablation depths of oneto two millimeters are normally enough to ablate the abnormal tissue inthe mucosa without significantly damaging the healthy tissue underneath.

[0087] Electrodes having an ablation index and viewing window accordingto the present invention may be used in other surgical instruments suchas, for example, endocutters. Further, electrodes having an ablationindex according to the present invention may be used for other treatmentregimens such as tissue welding, electrophoresis and coagulation ofvaricose veins and hemorrhoids.

[0088] While preferred embodiments of the present invention have beenshown and described herein, it will be obvious to those skilled in theart that such embodiments are provided by way of example only. Numerousvariations, changes, and substitutions will now occur to those skilledin the art without departing from the invention. For example, theendoscopic ablation system of the present invention also has applicationin robotic-assisted medical procedures. Accordingly, it is intended thatonly the spirit and scope of the appended claims limit the invention.

What is claimed is:
 1. An endoscopic ablation system for use with aflexible endoscope for electrosurgically treating bodily tissue of apatient, said endoscopic ablation system comprising: at least twoelectrodes; an ablation cap for creating space in the lumen of a bodilyorgan, wherein said ablation cap includes a rigid support member, and atleast two electrodes are positioned on said rigid support member; a sideopening in said rigid support member, said side opening in closeproximity to said at least two electrodes; an RF generator electricallyconnected to said at least two electrodes, wherein the operator mayactuate said RF generator to ablate tissue between said electrodes; asheath attached to said rigid support member, wherein the distal end ofthe flexible endoscope may be inserted through said sheath and at leastpartially into said ablation end cap; and a seal located near theproximal end of said sheath, said seal adapted to allow passage of thedistal end of the flexible endoscope, whereby said sheath and saidablation cap form an enclosure substantially sealed from the airexternal to the patient.
 2. An endoscopic ablation system according toclaim 1, wherein said ablation cap further comprises a tapered endcover.
 3. An endoscopic ablation system according to claim 2, whereinsaid tapered end cover is normally closed and is adapted to open inorder to allow passage of the distal end of an endoscope therethrough.4. An endoscopic ablation system according to claim 2, wherein saidtapered end cover is normally open and is adapted to allow passage ofthe distal end of an endoscope therethrough.
 5. An endoscopic ablationsystem according to claim 2, wherein said tapered end cover is made froma transparent, flexible material and is shaped like a bougie tube and isadapted to be passed over a guide wire.
 6. An endoscopic ablation systemaccording to claim 1 further including a rotation knob attached at theproximal end of said sheath.
 7. An endoscopic ablation system accordingto claim 1 further including a timer electrically connected in seriesbetween said electrodes and said RF generator, wherein said timerelectrically connects the output of said RF generator to said electrodesfor a predetermined period of time when the operator switches on said RFgenerator.
 8. An endoscopic ablation system according to claim 8 furtherincluding an actuator, whereby said timer is operable only when theoperator actuates said actuator.
 9. An endoscopic ablation systemaccording to claim 1 further including a viewing window between anadjacent pair of at least two electrodes, and said viewing window ismade of a transparent material and forms a portion of said rigid supportmember.
 10. An endoscopic ablation system according to claim 1 furtherincluding a flexible coupling made of a highly flexible material thatconnects the distal end of said sheath to said rigid support member. 11.A method of ablating tissue on the interior lining of a lumen of abodily organ, said method comprising: providing a flexible endoscopehaving aspiration means; providing an endoscopic ablation system,wherein said endoscopic ablation system comprises: at least twoelectrodes; an ablation cap for creating space in the lumen of a bodilyorgan, wherein said at least two electrodes are positioned on saidablation cap, and said ablation cap includes a relatively rigid supportmember; a viewing window between an adjacent pair of said at least twoelectrodes, wherein said viewing window is made of a transparentmaterial and forms at least a part of said rigid support member; an RFgenerator electrically connected to said at least two electrodes,wherein the operator may actuate said RF generator to ablate tissuebetween said electrodes; a sheath, wherein the distal end of said sheathis attached to said rigid support member by a flexible coupling made ofa highly flexible material, and the distal end of the flexible endoscopemay be inserted through said sheath, said flexible coupling, and atleast partially into said ablation end cap; and a seal located near theproximal end of said sheath, said seal adapted to allow passage of thedistal end of the flexible endoscope, whereby said sheath and saidablation cap form an enclosure substantially sealed from the airexternal to the patient, and said enclosure is fluidly connected to theinterior of the lumen of the bodily organ; inserting the distal end ofsaid flexible endoscope into said sheath and at least partially intosaid ablation cap; intubating the distal end of said flexible endoscopewith said sheath and said ablation cap into the lumen of a bodily organ;positioning under endoscopic visualization said viewing window againsttissue to be treated; actuating the aspiration means on the flexibleendoscope to evacuate air and other fluids from the lumen of the bodilyorgan next to said rigid support member, thereby causing the lumen ofthe bodily organ to collapse around said rigid support member, andbringing said viewing window and said electrodes into intimate contactwith the interior lining of the lumen of the bodily organ; and actuatingsaid RF generator to ablate the tissue between said electrodes.
 12. Amedical apparatus comprising: a sheath; a lumen support member disposedat a distal end of the sheath, the support member having a central boreand a side opening; and a seal for restricting fluid flow through thesheath.
 13. The apparatus of claim 12 wherein the support membercomprises first and second electrodes, and wherein the side opening inthe support member is disposed opposite the first and second electrodes.14. The apparatus of claim 12 wherein the support member is relativelyrigid with respect to the sheath.
 15. The apparatus of claim 12 whereinthe support member is transparent.
 16. The apparatus of claim 12 whereinthe seal is disposed in a proximal portion of the sheath.
 17. Theapparatus of claim 12 wherein the support member is flexibly coupled tothe sheath.
 18. A method of ablating tissue on the interior lining of abody lumen, the method comprising: providing a support member forstabilizing a portion of the body lumen, the support member having aside opening therein; positioning first and said second electrodes at atissue site to be treated; operatively associating a vacuum source withthe side opening in the support member; and ablating tissue with theelectrodes.
 19. The method of claim 20 further comprising the step ofviewing tissue between the electrodes during the step of ablatingtissue.
 20. The method of claim 20 wherein the electrodes are disposedon the support member, and wherein the side opening is positioned in thesupport member opposite from the first and second electrodes.
 21. Amedical apparatus comprising: a hollow support member having a centralbore extending along the length of the support member; and at least twoelectrodes disposed on the support member; wherein the support membercomprises a side opening.
 22. The apparatus of claim 22 wherein thesupport member has a generally cylindrical outside shape.
 23. Theapparatus of claim 22 wherein at least a portion of the support memberbetween the first and second electrodes is substantially transparent toallow viewing of tissue disposed between the electrodes.
 24. Theapparatus of claim 22 wherein the side opening is disposed on thesupport member opposite the first and second electrodes.